Completed

A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3

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What is being tested

Interferon alfa-2a

+ Zidovudine

+ Zalcitabine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects. Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. Mean duration of follow-up is expected to be 13 months.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine). Phenytoin for < grade 2 peripheral neuropathy. A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP). Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis. Patients must have: HIV infection. CD4 count < 400 cells/mm3 within 30 days prior to study entry. NOTE: Minimal Kaposi's sarcoma is allowed. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Active opportunistic infection requiring acute therapy. Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection. Malignancy (other than minimal Kaposi's sarcoma) requiring therapy. Grade 2 or worse peripheral neuropathy. Concurrent Medication: Excluded: Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs). Recombinant erythropoietin, G-CSF, or GM-CSF. Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs). Concurrent Treatment: Excluded: Radiation therapy (unless approved by the protocol chairs). Patients with the following prior conditions are excluded: History of intolerance to AZT at 600 mg/day or less. Unexplained temperature of 38.5 degrees C persisting for 14 days or longer. Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14 days or longer. Prior Medication: Excluded: Acute therapy for opportunistic infection within 14 days prior to study entry. Prior ddC, ddI, or IFN alfa-2a. Active substance abuse.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Alabama Therapeutics CRS

Birmingham, United StatesOpen Alabama Therapeutics CRS in Google Maps

Ucsd, Avrc Crs

La Jolla, United States

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, United States

Univ. of Miami AIDS CRS

Miami, United States
Completed4 Study Centers